Application 202167
- Type
- ANDA
- Sponsor
- DEXCEL PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-387 | Levetiracetam | Levetiracetam | AvKARE, Inc. | ANDA | Current |
| 42291-388 | Levetiracetam | Levetiracetam | AvKARE, Inc. | ANDA | Current |
| 69076-500 | Levetiracetam | Levetiracetam | Quinn Pharmaceuticals, LLC | ANDA | Current |
| 69076-500 | Levetiracetam | Levetiracetam | Florida Pharmaceutical Products, LLC. | ANDA | Current |
| 69076-750 | Levetiracetam | Levetiracetam | Quinn Pharmaceuticals, LLC | ANDA | Current |
| 69076-750 | Levetiracetam | Levetiracetam | Florida Pharmaceutical Products, LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9982 | ORIG | 2015-09-09 |